In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards. • Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4) • Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives • Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications) • Lead study timelines for regulatory documents and regulatory submission strategy • Act as a functional area representative and lead on product teams • Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance • Ensure quality of regulatory submission documents at all stages of development • Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams • Participate in departmental meetings, as well as departmental and cross-departmental initiatives
Basic Qualifications: Doctorate degree Or Master’s degree and 3 years of Writing Regulatory or scientific submission/documents experience Or Bachelor’s degree and 5 years of Writing Regulatory or scientific submission/documents experience Or Associate’s degree and 10 years of Writing Regulatory or scientific submission/documents experience Or High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience
Preferred Qualifications: • Masters or higher degree in biology, chemistry, or other scientific field • 5+ years in writing clinical and regulatory documents • Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment • Ability to analyze medical data and interpret its significance • Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance • Strong written/oral communication skills and attention to detail • Understanding and application of principles, concepts, theories, and standards of scientific/technical field • Strong time and project management skills, engaging approach, and perseverance with a drive for results • Leadership skills and ability to guide and influence the work of others • Strong leadership in a collaborative team environment
Top 3 Must Have Skill Sets: Must have experience briefing documents with significant clinical content/Module 2 clinical summary documents. Looking for 3-5 years of experience with these document types • Masters or higher degree in biology, chemistry, or other scientific field • 5+ years in writing clinical and regulatory documents • Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment • Ability to analyze medical data and interpret its significance • Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance
Day to Day Responsibilities: In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards. • Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4) • Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives • Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications) • Lead study timelines for regulatory documents and regulatory submission strategy • Act as a functional area representative and lead on product teams • Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance • Ensure quality of regulatory submission documents at all stages of development • Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams • Participate in departmental meetings, as well as departmental and cross-departmental initiatives
Possible Extension: Yes Red Flags: Please review above Interview Process: Phone screens and video conference
Note: The Company is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $36.00/hr.
